INFLUENCE OF OXYBUTYNIN - MEDRING LIGALLI ON OVERACTIVE BLADDER SYMPTOMS IN WOME
- Conditions
- urinary urge incontinenceTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2021-003929-30-BE
- Lead Sponsor
- igalli BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 9
1.Willing to give written informed consent and willing and able to comply with the study protocol.
2.Female subjects aged between 18 and 70 years (inclusive)
3.Women diagnosed with OAB according to the definition of the International Continence Society (ICS), and responding with a score 3 or higher on question 5a of the ICIQ questionnaire do you have to rush to the toilet to urinate”?
4.Subject is in good general health, according to the investigator’s judgement based on medical history, vital signs, physical examination, electrocardiogram (ECG), and laboratory tests performed.
5.Body mass index between 18-32 kg·m2 (inclusive) and with a minimum body weight of 50 kg at screening.
6.Ability to communicate well with the investigator in the Dutch language and willing to comply with the study restrictions.
7.Using adequate contraception (if applicable).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1
1.Presence of virginity.
2.History of sexual abuse/violence.
3.Menstrual bleeding or withdrawal bleeding from oral contraceptive pill expected to occur during conduction of the study.
4.Positive urinary pregnancy test at screening or at baseline and/or lactating.
5.Having given birth vaginally or by caesarean section 6 months prior to screening
6.Having had sexual intercourse or objects inserted vaginally that could potentially lacerate or damage the vaginal wall 24 hours prior to dosing.
7.Medical history of intra- and/or transvaginal operations that in the opinion of the investigator may interfere with placement or stability of the MedRing or absorption of oxybutynin.
8.Any known significant allergic reactions (urticaria or anaphylaxis) against oxybutynin, or multiple drug allergies (non-active hay fever is acceptable), or known hypersensitivity to components of the MedRing (polypropylene, styrene triblock copolymer, coloring agents, coating, glue).
9.Participation in any marketed or investigational drug or device study within 3 months or 5 half-lives (whichever is longer) prior to dosing.
10.Botox administration in the pelvic area less than 12 months ago.
11.Use of any prescription medication and any other substance that in the opinion of the investigators may influence the outcome of the study within 21 days prior to dosing.
12.Use of alcohol during the 24 hours prior to Day 1 of the study.
13.Any other condition that in the opinion of the investigator would complicate or compromise the study or the well-being of the subject.
14.Presence of significant postvoid residual urine determined as >100 ml estimated by ultrasound immediately postvoiding.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method